BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 18760320 · Received February 22, 2024

    Report

    Report Number
    1911916-2024-00137
    Event Type
    Malfunction
    Date Received
    February 22, 2024
    Date of Event
    January 25, 2024
    Report Date
    March 20, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    30382903065470
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED EVENT DATE 25-JAN-2024.

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP. IT WAS REPORTED THERE WAS A BLOOD SPLAT OUTSIDE THE PISTON. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE COMPLETED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH NO PACKAGING BLISTER OR TIP CAP. THE BOTTOM PART OF THE SYRINGE HAS BLOOD AND THERE IS ALSO BLOOD PAST THE STOPPER. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS PRODUCT IS SINGLE USE AND IS NOT DESIGNED TO PULL THE PLUNGER ROD BACK. AFTER THE SALINE SOLUTION HAS BEEN EXPELLED THE SYRINGE SHOULD BE DISCARDED. IF THE PRODUCT IS NOT MEETING THE CUSTOMER¿S NEEDS, IT MAY BE BENEFICIAL TO CONTACT THE LOCAL BD SALES, OR MARKETING REPRESENTATIVE, FOR ADDITIONAL PRODUCT OPTIONS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306547, LOT 3090897. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    MATERIAL #: 306547, BATCH#: 3090897, 3333571, 3271933. IT WAS REPORTED BY CUSTOMER THAT THERE WAS A BLOOD SPLAT OUTSIDE THE PISTON. VERBATIM: "I HAVE HAD ANOTHER ISSUE WITH A BD SYRINGE. HERE IS A PICTURE BELOW AND YOU CAN SEE THE LOT NUMBER. WE USE THESE SYRINGES TO IRRIGATE OUR HEMODIALYSIS CATHETER. THIS PROBLEM HAPPENED IN OUR SATELLITE UNIT IN MIRAMICHI NEW-BRUNSWICK. DURING IRRIGATION, THERE WAS A BLOOD LEAK (IF YOU CAN SEE IN THE PICTURE THERE WAS A BLOOD SPLAT OUTSIDE THE PISTON). " ADDITIONAL INFORMATION: THOSE INCIDENT DID HAPPENED ON A DAILY BASIS, AT LEASE TWICE DAILY. WE NOW HAVE THE SAME ISSUE WITH A DIFFERENT ONE. LOT NUMBER 3333571,REF (B)(4). OCCURRED DURING FLUSH OF THE CATHETER, WHEN PULLING THE PLUNGER.

    Description of Event or Problem · 0

    MATERIAL #: 306547; BATCH#: 3090897, 3333571, 3271933. IT WAS REPORTED BY CUSTOMER THAT THERE WAS A BLOOD SPLAT OUTSIDE THE PISTON. VERBATIM: "I HAVE HAD ANOTHER ISSUE WITH A BD SYRINGE. HERE IS A PICTURE BELOW AND YOU CAN SEE THE LOT NUMBER. WE USE THESE SYRINGES TO IRRIGATE OUR HEMODIALYSIS CATHETER. THIS PROBLEM HAPPENED IN OUR SATELLITE UNIT IN MIRAMICHI NEW-BRUNSWICK. DURING IRRIGATION, THERE WAS A BLOOD LEAK (IF YOU CAN SEE IN THE PICTURE THERE WAS A BLOOD SPLAT OUTSIDE THE PISTON). " ADDITIONAL INFORMATION: THOSE INCIDENT DID HAPPENED ON A DAILY BASIS, AT LEASE TWICE DAILY. WE NOW HAVE THE SAME ISSUE WITH A DIFFERENT ONE. LOT NUMBER 3333571,REF 306547. OCCURRED DURING FLUSH OF THE CATHETER, WHEN PULLING THE PLUNGER.

    Description of Event or Problem · 0

    MATERIAL #: 306547. BATCH#: 3090897. IT WAS REPORTED BY CUSTOMER THAT THERE WAS A BLOOD SPLAT OUTSIDE THE PISTON. VERBATIM: "I HAVE HAD ANOTHER ISSUE WITH A BD SYRINGE. HERE IS A PICTURE BELOW AND YOU CAN SEE THE LOT NUMBER. WE USE THESE SYRINGES TO IRRIGATE OUR HEMODIALYSIS CATHETER. THIS PROBLEM HAPPENED IN OUR SATELLITE UNIT IN MIRAMICHI NEW-BRUNSWICK. DURING IRRIGATION, THERE WAS A BLOOD LEAK (IF YOU CAN SEE IN THE PICTURE THERE WAS A BLOOD SPLAT OUTSIDE THE PISTON). "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583922 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SYRINGE, PISTON FOZ BECTON DICKINSON 3090897 30382903065470
    67093 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SYRINGE, PISTON FOZ BECTON DICKINSON 3090897 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown